Food and Drug Administration

The Food and Drug Administration regulates the safety and effectiveness of food and food additives, drugs, cosmetics, medical devices, radiation-emitting devices, biologics, and animal feed and medicines (21 U.S.C. Ch. 9 et seq). The FDA is a division of the Department of Health and Human Services.

Organization

What does the FDA regulate?

The FDA has the power to regulate foods and food additives, drugs for both humans and animals, biological products, medical devices, cosmetics, and devices that emit radiation.

Category	Examples
Drugs (Regulated by CDER)	- Over-the-Counter medications - Prescription Drugs - Generic Drugs
Biologics (Regulated by CBER)	- Vaccines - Blood - Gene Therapies
Food & Cosmetics (Regulated by CFSAN)	- Food products (excluding meat) - Food additives (colors, fortifications, radiation) - Dietary Supplements - Bottled Water - Food packaging and labeling - Cosmetics
Medical Devices (Regulated by CDRH)	- Wheelchairs - Bandages - Contact Lenses - Prosthetic Limbs - MRI Machines
Radiation-Emitting Products (Regulated by CDRH)	- Microwave Ovens - Televisions - Medical X-ray machines - Baggage X-ray machines
Veterinary Products (Regulated by CVM)	- Livestock Feed - Pet Food - Animal Drugs

Some products the FDA does not regulate include:

• Meat and Poultry (regulated by the Food Safety and Inspection Service of the US Department of Agriculture (USDA))
• Tobacco & Alcohol (regulated by the Department of Justice’s Bureau of Alcohol, Tobacco, Firearms and Explosives)
• Illegal Drugs (controlled by the Drug Enforcement Agency)
• Restaurants (under the jurisdiction of local health departments)
• Water (regulated by the EPA).

Research by Margaret Rich